The Medical Devices Directives set out essential requirements to ensure that a medical device will not compromise the Health & Safety of the patient, user or any other person, and that any risks associated with the device are still compatible with patient health and protection.

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488(also 1996).

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